BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2874985 · Received December 17, 2012

    Report

    Report Number
    9612164-2012-01779
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ALLERGIC REACTION). CONCLUSION: UNABLE TO CONFIRM COMPLAINT (LIMITED INFORMATION AVAILABLE). KNOWN INHERENT RISK OF PROCEDURE (ALLERGIC REACTION). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN ALLERGIC REACTION FOLLOWING A RESOLUTE INTEGRITY (RX) DRUG ELUTING STENT DEPLOYMENT. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1